The US Food and Drug Administration (FDA) has granted cell-based seafood company Wildtype the approval to market its products, marking a significant milestone for the food manufacturing sector.
Following a pre-market consultation, the agency issued a “no questions” letter, affirming its alignment with Wildtype’s evaluation that its cultivated salmon is “safe” for consumption.
Wildtype’s production process initiates with the harvesting of source cells from fry-stage coho salmon (Oncorhynchus kisutch) sourced from a hatchery in Washington state.
The viable cells then proliferate in stainless steel bioreactors, utilizing Wildtype’s “proprietary” nutrient blend.
Subsequently, the harvested cells are seeded onto plant-based scaffolds and undergo rinsing, rigorous quality checks, conventional food processing, and packaging.
The FDA highlighted that Wildtype provided a comprehensive summary of its safety assessment, which spanned the years 2022 to 2025.
In its letter, the agency stated: “Based on the safety assessment Wildtype has conducted, it is our understanding that Wildtype has concluded that foods comprised of or containing the cultured cellular material resulting from the production process defined in CCC 000005 are as safe as comparable foods produced by other methods and would not contain substances that adulterate the food.”
Currently, Wildtype has launched its cultivated salmon at Kann, a restaurant located in Portland, Oregon.
According to the company’s blog, the weekly service of this product commenced in late May, with availability expanding to every Thursday night in June and plans for daily service starting in July.
Furthermore, Wildtype aims to introduce its product at four additional restaurants over the next four months.
In 2022, Wildtype raised $100m in a Series B funding round, with investment participation from US agribusiness giant Cargill.
Notably, two years ago, the US cleared cultivated chicken from Upside Foods and Good Meat for sale. Earlier this year, Mission Barns, a company developing animal fat in bioreactors, also received regulatory approval.
